#-supreme-cellcarta-differentiators-15-144{items-data:[{"text":"Regulatory Expertise"},{"text":"Assay Development "},{"text":"Dynamic Services "},{"text":"Personalized Support"},{"text":"Global Market Understanding "}]}#-supreme-cellcarta-faq-13-144{items-data:[{"faq_question":"Is IVDR required for US-based laboratories? ","faq_answer":"<p>IVDR is applicable whenever testing occurs on EU patient samples,irrespective of laboratory location,and when a testing laboratory employs clinical trial assays developed in-house or utilizes a CE-IVD kit for off-label use,provided that the test results serve a medical purpose.</p>"},{"faq_question":"Do trials from before May 26,2022,need a performance study application under IVDR? ","faq_answer":"No,based on competent authority feedback,a performance study application is not required under IVDR if study subjects consented to participation in the trial before May 26,2022. "},{"faq_question":"Are all assays used in a clinical trial subject to IVD legislation? ","faq_answer":"<p>No,exploratory assays not intended for medical management decisions of patient care or treatment,are not subject to IVDR. These include stratification and endpoint analysis,or other exploratory assays,for which correlation with clinical parameters is investigated retrospectively without impact on patient treatment (medical purpose).</p>\n<p><a href=\"/science-hub/infographic-ivdr/\" target=\"_self\"><span class=\"TextRun Highlight SCXW248804484 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun CommentStart CommentHighlightPipeClicked CommentHighlightClicked SCXW248804484 BCX0\">Read our infographic for further details</span><span class=\"NormalTextRun CommentHighlightPipeClicked SCXW248804484 BCX0\">.</span></span><span class=\"EOP Selected SCXW248804484 BCX0\" data-ccp-props=\"{\"335559738\":240,\"335559739\":240}\"> </span></a></p>"},{"faq_question":"What IVDR expertise does your team provide? ","faq_answer":"<p>Our team&rsquo;s expertise in IVDR and its previous version,IVDD,as well as assay and CDx development,ensures personalized support for your study. CellCarta has previously created or collaborated on 37 clinical performance study packages following IVDR legislation,across 27 EU countries,resulting in over 190 individual approvals.</p>"},{"faq_question":"Does IVDR apply to the UK? ","faq_answer":"No. Currently,the UK has not adopted IVDR and currently reviews clinical trial assays under the previous version,IVDD. Our regulatory team has the knowledge and experience to support the necessary dossier preparation and registration for testing UK patients under IVDD. "}]}#-supreme-cellcarta-featured-resources-16-144{cards-data:[{"image_url":"\/wp-content\/uploads\/2026\/05\/webinar.jpg","card_type":"Webinar","date":"Feb 12","reading_time":"Reading Time - 5 minutes","title":"Resources Title Goes Here","description":"Lorem ipsum dolor sit amet,consectetuer adipiscing elit. Aenean commodo ligula eget dolor.","url":"#"},{"image_url":"\/wp-content\/uploads\/2026\/05\/webinar-2.jpg","card_type":"Webinar","date":"Feb 12","reading_time":"Reading Time - 5 minutes","title":"Resources Title Goes Here","description":"Lorem ipsum dolor sit amet,consectetuer adipiscing elit. Aenean commodo ligula eget dolor.","url":"#"},{"image_url":"\/wp-content\/uploads\/2026\/05\/webinar-3.jpg","card_type":"Webinar","date":"Feb 12","reading_time":"Reading Time - 5 minutes","title":"Resources Title Goes Here","description":"Lorem ipsum dolor sit amet,consectetuer adipiscing elit. Aenean commodo ligula eget dolor.","url":"#"}]}#-supreme-cellcarta-service-blocks-45-176{blocks-data:[{"image":"https://cellcarta.com/wp-content/uploads/2026/06/Sample-Logistics-Hero-404.jpg","image_alt":"","title":"Sample Logistics","description":"Global sample management,transport,and biorepository services.","button_text":"Discover","button_url":"/clinical-trial-services/sample-logistics/","button_target":"_self"},{"image":"/wp-content/uploads/2026/06/IVDR-Service-834.jpg","image_alt":"","title":"Quality Management Systems ","description":"Our QMS is embedded across every stage of your study,from planning to reporting and archiving. ","button_text":"Discover","button_url":"/clinical-trial-services/regulatory-services/laboratory-quality-management-system/","button_target":"_self"},{"image":"https://cellcarta.com/wp-content/uploads/2026/06/Clinical-Trial-Hero-814.jpg","image_alt":"","title":"Clinical Trial Services ","description":"Support across all clinical trials,delivering expertise in biomarkers,regulation,data analytics,and more. ","button_text":"Discover","button_url":"/clinical-trial-services/","button_target":"_self"}]}